Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Interventions to Increase HBV Vaccinations in Sexually Transmitted Disease (STD) Clinics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00739752
Recruitment Status : Completed
First Posted : August 22, 2008
Results First Posted : October 16, 2017
Last Update Posted : November 9, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Gregory Zimet, Indiana University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Hepatitis B Virus
Interventions Behavioral: Non-Framed-Offered
Behavioral: Non-Framed-Recommended
Behavioral: Gain-Framed-Offered
Behavioral: Gain-Framed-Recommended
Behavioral: Loss-Framed-Offered
Behavioral: Loss-Framed-Recommended
Enrollment 1747
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Non-Framed-Offered Non-Framed-Recommended Gain-Framed-Offered Gain-Framed-Recommended Loss-Framed-Offered Loss-Framed-Recommended
Hide Arm/Group Description

Non-Framed, Information Only Condition. Vaccine Offered.

Non-Framed-Offered: Subjects received information only and are offered the vaccine.

Non-Framed, Information Only Condition. Vaccine Recommended.

Non-Framed-Recommended: Subjects receive information only and are recommended the vaccine.

Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Offered.

Gain-Framed-Offered: Subjects receive gain-framed messages and are offered the vaccine.

Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Recommended.

Gain-Framed-Recommended: Subjects receive gain-framed messages and are recommended the vaccine.

Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Offered.

Loss-Framed-Offered: Subjects receive loss-framed messages and are offered the vaccine.

Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Recommended.

Loss-Framed-Recommended: Subjects receive loss-framed messages and are recommended the vaccine.

Period Title: Overall Study
Started 299 284 292 288 291 293
Completed 299 284 292 288 291 293
Not Completed 0 0 0 0 0 0
Arm/Group Title Non-Framed-Offered Non-Framed-Recommended Gain-Framed-Offered Gain-Framed-Recommended Loss-Framed-Offered Loss-Framed-Recommended Total
Hide Arm/Group Description

Non-Framed, Information Only Condition. Vaccine Offered.

Non-Framed-Offered: Subjects received information only and are offered the vaccine.

Non-Framed, Information Only Condition. Vaccine Recommended.

Non-Framed-Recommended: Subjects receive information only and are recommended the vaccine.

Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Offered.

Gain-Framed-Offered: Subjects receive gain-framed messages and are offered the vaccine.

Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Recommended.

Gain-Framed-Recommended: Subjects receive gain-framed messages and are recommended the vaccine.

Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Offered.

Loss-Framed-Offered: Subjects receive loss-framed messages and are offered the vaccine.

Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Recommended.

Loss-Framed-Recommended: Subjects receive loss-framed messages and are recommended the vaccine.

Total of all reporting groups
Overall Number of Baseline Participants 299 284 292 288 291 293 1747
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 299 participants 284 participants 292 participants 288 participants 291 participants 293 participants 1747 participants
31.2  (9.7) 31.8  (9.8) 31.2  (9.8) 31.7  (9.4) 32.1  (10.1) 32.3  (10.6) 31.7  (9.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 299 participants 284 participants 292 participants 288 participants 291 participants 293 participants 1747 participants
Female
178
  59.5%
179
  63.0%
175
  59.9%
166
  57.6%
179
  61.5%
177
  60.4%
1054
  60.3%
Male
121
  40.5%
105
  37.0%
117
  40.1%
122
  42.4%
112
  38.5%
116
  39.6%
693
  39.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 299 participants 284 participants 292 participants 288 participants 291 participants 293 participants 1747 participants
Hispanic or Latino
7
   2.3%
9
   3.2%
9
   3.1%
8
   2.8%
6
   2.1%
9
   3.1%
48
   2.7%
Not Hispanic or Latino
284
  95.0%
272
  95.8%
278
  95.2%
275
  95.5%
282
  96.9%
278
  94.9%
1669
  95.5%
Unknown or Not Reported
8
   2.7%
3
   1.1%
5
   1.7%
5
   1.7%
3
   1.0%
6
   2.0%
30
   1.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 299 participants 284 participants 292 participants 288 participants 291 participants 293 participants 1747 participants
American Indian or Alaska Native
1
   0.3%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.1%
Asian
0
   0.0%
1
   0.4%
2
   0.7%
0
   0.0%
1
   0.3%
2
   0.7%
6
   0.3%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.3%
0
   0.0%
0
   0.0%
1
   0.1%
Black or African American
252
  84.3%
233
  82.0%
239
  81.8%
233
  80.9%
236
  81.1%
233
  79.5%
1426
  81.6%
White
32
  10.7%
37
  13.0%
37
  12.7%
38
  13.2%
35
  12.0%
45
  15.4%
224
  12.8%
More than one race
8
   2.7%
8
   2.8%
5
   1.7%
6
   2.1%
7
   2.4%
9
   3.1%
43
   2.5%
Unknown or Not Reported
6
   2.0%
5
   1.8%
9
   3.1%
10
   3.5%
12
   4.1%
4
   1.4%
46
   2.6%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 299 participants 284 participants 292 participants 288 participants 291 participants 293 participants 1747 participants
299
 100.0%
284
 100.0%
292
 100.0%
288
 100.0%
291
 100.0%
293
 100.0%
1747
 100.0%
1.Primary Outcome
Title Mean Number of Doses of HBV Vaccine Received
Hide Description Mean Number of HBV vaccine doses received over an 8-month period, including the clinic visit. Count values ranged from 0 to 3 doses.
Time Frame Day of research visit with 8 month follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Non-Framed-Offered Non-Framed-Recommended Gain-Framed-Offered Gain-Framed-Recommended Loss-Framed-Offered Loss-Framed-Recommended
Hide Arm/Group Description:

Non-Framed, Information Only Condition. Vaccine Offered.

Non-Framed-Offered: Subjects received information only and are offered the vaccine.

Non-Framed, Information Only Condition. Vaccine Recommended.

Non-Framed-Recommended: Subjects receive information only and are recommended the vaccine.

Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Offered.

Gain-Framed-Offered: Subjects receive gain-framed messages and are offered the vaccine.

Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Recommended.

Gain-Framed-Recommended: Subjects receive gain-framed messages and are recommended the vaccine.

Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Offered.

Loss-Framed-Offered: Subjects receive loss-framed messages and are offered the vaccine.

Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Recommended.

Loss-Framed-Recommended: Subjects receive loss-framed messages and are recommended the vaccine.

Overall Number of Participants Analyzed 299 284 292 288 291 293
Mean (Standard Deviation)
Unit of Measure: Doses of HBV Vaccine
.78  (1.00) .85  (1.02) .94  (1.11) .98  (1.06) .81  (1.04) 1.10  (1.14)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Gain-Framed-Offered, Gain-Framed-Recommended, Loss-Framed-Offered, Loss-Framed-Recommended
Comments The two gain-framed groups were compared to the two loss-framed groups using poisson regression.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value =.885
Comments [Not Specified]
Method Regression, Poisson
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
.88 to 1.12
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Non-Framed-Offered, Non-Framed-Recommended, Gain-Framed-Offered, Gain-Framed-Recommended, Loss-Framed-Offered, Loss-Framed-Recommended
Comments Groups receiving any framed interventions (gain-framed or loss-framed) were compared to those in the two non-framed control groups.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.01
Comments [Not Specified]
Method Regression, Poisson
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.17
Confidence Interval (2-Sided) 95%
1.06 to 1.31
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Non-Framed-Offered, Non-Framed-Recommended, Gain-Framed-Offered, Gain-Framed-Recommended, Loss-Framed-Offered, Loss-Framed-Recommended
Comments The 3 vaccine-recommended groups were compared with the 3 vaccine-offered groups using poisson regression.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.01
Comments [Not Specified]
Method Regression, Poisson
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio (RR)
Estimated Value 1.16
Confidence Interval (2-Sided) 95%
1.05 to 1.28
Estimation Comments [Not Specified]
Time Frame 8 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Non-Framed-Offered Non-Framed-Recommended Gain-Framed-Offered Gain-Framed-Recommended Loss-Framed-Offered Loss-Framed-Recommended
Hide Arm/Group Description

Non-Framed, Information Only Condition. Vaccine Offered.

Non-Framed-Offered: Subjects received information only and are offered the vaccine.

Non-Framed, Information Only Condition. Vaccine Recommended.

Non-Framed-Recommended: Subjects receive information only and are recommended the vaccine.

Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Offered.

Gain-Framed-Offered: Subjects receive gain-framed messages and are offered the vaccine.

Gain-Framed Intervention emphasizes the benefits associated with receiving HBV vaccine. Vaccine Recommended.

Gain-Framed-Recommended: Subjects receive gain-framed messages and are recommended the vaccine.

Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Offered.

Loss-Framed-Offered: Subjects receive loss-framed messages and are offered the vaccine.

Loss-Framed Intervention emphasizes the risks associated with not receiving HBV vaccine. Vaccine Recommended.

Loss-Framed-Recommended: Subjects receive loss-framed messages and are recommended the vaccine.

All-Cause Mortality
Non-Framed-Offered Non-Framed-Recommended Gain-Framed-Offered Gain-Framed-Recommended Loss-Framed-Offered Loss-Framed-Recommended
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/299 (0.00%)   0/284 (0.00%)   0/292 (0.00%)   0/288 (0.00%)   0/291 (0.00%)   0/293 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Non-Framed-Offered Non-Framed-Recommended Gain-Framed-Offered Gain-Framed-Recommended Loss-Framed-Offered Loss-Framed-Recommended
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/299 (0.00%)   0/284 (0.00%)   0/292 (0.00%)   0/288 (0.00%)   0/291 (0.00%)   0/293 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Non-Framed-Offered Non-Framed-Recommended Gain-Framed-Offered Gain-Framed-Recommended Loss-Framed-Offered Loss-Framed-Recommended
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/299 (0.00%)   0/284 (0.00%)   0/292 (0.00%)   0/288 (0.00%)   0/291 (0.00%)   0/293 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Gregory Zimet
Organization: Indiana University
Phone: 317-274-8812
EMail: gzimet@iu.edu
Publications of Results:
Cox AD, Cox D, Zimet G. Promoting prevention and early detection: The impact of message framing, product function and perceived product risk. J Marketing 2006;70:79-91.
Layout table for additonal information
Responsible Party: Gregory Zimet, Indiana University
ClinicalTrials.gov Identifier: NCT00739752     History of Changes
Other Study ID Numbers: 0205-04
R01AI049644 ( U.S. NIH Grant/Contract )
First Submitted: August 20, 2008
First Posted: August 22, 2008
Results First Submitted: April 6, 2017
Results First Posted: October 16, 2017
Last Update Posted: November 9, 2018